Regulatory Affairs Executive

Regulatory Affairs Executive (Contract Basis) (Ref: 37818)
Location: Central

【 Responsibilities 】

1) Regulatory Affairs

Manage product registrations and product life cycle activities in Singapore and Malaysia.
Handle new product registrations, renewals, variations, change notifications and other post-approval activities.
Review product labelling, packaging materials and promotional materials to ensure compliance with applicable regulatory requirements.
Prepare and submit regulatory dossiers and respond to queries from HSA, NPRA and other relevant regulatory authorities.
Monitor regulatory changes and provide regulatory updates and impact assessments to relevant stakeholders.
Work closely with Supply Chain, Commercial, Medical, Pharmacovigilance, Quality and other functions to support product launches, product changes and continuity of supply.
Maintain regulatory databases, submission records and related documentation.
Identify opportunities to improve regulatory processes and operational efficiency.

2) Quality Assurance / Quality Management

Applicable where the employee is formally appointed as the Responsible Person.

Act as the Responsible Person for the Therapeutic Products Importer’s Licence and Wholesaler’s Licence.
Oversee GDP-related quality activities covering product importation, storage and distribution.
Oversee product release, returns, recalls, holds and other product disposition activities, as applicable.
Support health authority inspections and GDP self-inspections.
Support the management of deviations, product complaints, CAPA and other quality-related matters.
Support the oversight of distributors, logistics service providers and relevant third parties.

3) Others

Review promotional and non-promotional materials for compliance with applicable regulatory requirements.
Collaborate with local, regional and global stakeholders to ensure the timely completion of regulatory and quality activities.
Support regulatory activities in Malaysia and work closely with the Malaysia regulatory team.
Support regulatory and quality audits and inspections.
Guide and support junior team members and new joiners.
Perform other regulatory and quality-related duties as assigned based on business needs.

【 What you will receive 】

【Requirements & Preferences】

Bachelor’s degree in Pharmacy, Pharmaceutical Science, Life Sciences or another relevant discipline.
At least 2 years of relevant Regulatory Affairs experience within the Singapore pharmaceutical industry.
Proficiency in English to communicate effectively with relevant internal and external stakeholders.
Demonstrated experience in preparing and managing regulatory submissions and post-approval activities in Singapore.
Strong understanding of regulatory requirements and their potential impact on product registrations, supply, labelling and related business processes.
Experience in managing product life cycle activities, including variations, renewals, change assessments, labelling updates and responses to health authority queries.
Ability to independently manage multiple regulatory activities and deliverables within agreed timelines.

(Advantageous)

Registered pharmacist with the Singapore Pharmacy Council and eligible for appointment as the Responsible Person for the company’s Therapeutic Products Importer’s Licence and Wholesaler’s Licence.
Regulatory Affairs experience within the Malaysia pharmaceutical industry, including familiarity with National Pharmaceutical Regulatory Agency requirements.
Experience supporting regulatory activities across both Singapore and Malaysia.
Experience with different product types, such as chemical drugs, biologics and drug-device combination products.
Knowledge of Good Distribution Practice requirements and experience supporting quality operations, health authority inspections or self-inspections.

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We regret that only shortlisted candidates will be notified.

Registration No.: R1874034 (Niltasha Binte Ibrahim)
Recruitment Licence: 12C5051

See also